Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01843374 · OUTCOME

Progression-free Survival by Treatment Arm

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma · Source last updated 2026-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.

What was measured

Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Analysis population: ITT population

Groups in this outcome

TREMELIMUMAB

Tremelimumab 10mg/kg

PLACEBO

Placebo.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
TREMELIMUMAB382
PLACEBO189

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TREMELIMUMAB2.69Not reported2.662.76Not reported
PLACEBO2.76Not reported2.762.79Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.68
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.98
    estimate Comment
    Tremelimumab is the numerator and placebo, the denominator
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0325
    p Value Comment
    Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
    statistical Comment
    Stratification factors were EORTC status and Line of therapy
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.68
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.98
    estimate Comment
    Tremelimumab is the numerator and placebo, the denominator
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0325
    p Value Comment
    Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
    statistical Comment
    Stratification factors were EORTC status and Line of therapy
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.66
        upper Limit
        2.76
        value
        2.69
      2. group Id
        OG001
        lower Limit
        2.76
        upper Limit
        2.79
        value
        2.76
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      382
    2. group Id
      OG001
      value
      189
    units
    Participants
description
Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tremelimumab 10mg/kg
    id
    OG000
    title
    TREMELIMUMAB
  2. description
    Placebo.
    id
    OG001
    title
    PLACEBO
param Type
MEDIAN
population Description
ITT population
reporting Status
POSTED
time Frame
Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
title
Progression-free Survival by Treatment Arm
type
SECONDARY
type Units Analyzed
Participants
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice